The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues.

The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.

Patient is indicated for and has consented to FESS.

FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.

CT Imaging Inclusion Criteria:

CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253577